UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000042563
Receipt number R000048583
Scientific Title Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance
Date of disclosure of the study information 2020/11/26
Last modified on 2021/09/01 17:26:19

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Basic information

Public title

Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance

Acronym

Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance

Scientific Title

Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance

Scientific Title:Acronym

Examination of the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre for employees suspected of having impaired glucose tolerance

Region

Japan


Condition

Condition

Healthy Adults

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To verify the effectiveness of the lifestyle change program focusing on eating behavior by using FreeStyle Libre

Basic objectives2

Efficacy

Basic objectives -Others


Trial characteristics_1


Trial characteristics_2


Developmental phase



Assessment

Primary outcomes

Time In Range at 1W, 2W, 3W, and 4W.

Key secondary outcomes

The items below are evaluated at 1W, 2W, 3W, and 4W.
1)Standard deviation of blood glucose level
2)Percentage of time above Time In Range and percentage of time below Time In Range
3)Estimated HbA1c
4)Average blood glucose level
5)Number of low glucose events
6)Number of spikes
7)Number of scans by reader
The item below is evaluated at 1W, 4W, and 8W.
8)Behavioral change
The item below is evaluated at 1W and 4W.
9)BMI
The item below is evaluated by pictures.
10)Change of meal contents



Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification


Dynamic allocation


Institution consideration


Blocking


Concealment



Intervention

No. of arms

1

Purpose of intervention

Prevention

Type of intervention

Device,equipment

Interventions/Control_1

Measuring blood glucose level by freestyle libre at 1W, 2W, 3W, and 4W, provision of messages between 1W and 4W and doctor reports after 1W and 4W by app.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

30 years-old <=

Age-upper limit

64 years-old >=

Gender

Male and Female

Key inclusion criteria

1)HbA1c was 5.6% -6.9% in the results of medical examinations for the last 2 years.
2)Diagnosed as hypertension and dyslipidemia but not diabetes
3)Consent was obtained from the subject participated in the preliminary briefing session of this study
4)Understand the purpose of research and use Libre properly
5)Daily use of smartphone

Key exclusion criteria

1)Diagnosed as diabetes
2)Having severe kidney disease, liver disease, heart disease, malignant tumor, etc.
3)May be pregnant or within 1 year after childbirth
4)Researchers judge that the participation in the research is inappropriate
5)Consent was obtained from the proxy

Target sample size

70


Research contact person

Name of lead principal investigator

1st name Jun
Middle name
Last name Fujita

Organization

SOMPO Health Support Inc.

Division name

Information system Department

Zip code

101-0063

Address

Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo

TEL

0352098500

Email

jfujita46@sompo-hs.co.jp


Public contact

Name of contact person

1st name Hiromasa
Middle name
Last name Ida

Organization

SOMPO Health Support Inc.

Division name

Business Planning & Development Department

Zip code

101-0063

Address

Kanda Awaji-cho 1-2-3, Chiyoda-ku, Tokyo

TEL

0352098523

Homepage URL


Email

hida89@sompo-hs.co.jp


Sponsor or person

Institute

SOMPO Health Support Inc.

Institute

Department

Personal name



Funding Source

Organization

Sompo Holdings, Inc,

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization



Other related organizations

Co-sponsor


Name of secondary funder(s)



IRB Contact (For public release)

Organization

Yamate Hifuka Clinic IRB

Address

ST Shibuya Building, Dougenzaka 1-15-14, Shibuya-ku, Tokyo

Tel

0364169032

Email

yamate@clinic-irb.com


Secondary IDs

Secondary IDs

NO

Study ID_1


Org. issuing International ID_1


Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions



Other administrative information

Date of disclosure of the study information

2020 Year 11 Month 26 Day


Related information

URL releasing protocol

Unpublished due to the protocol including the intellectual property rights

Publication of results

Unpublished


Result

URL related to results and publications

Working in progress

Number of participants that the trial has enrolled

50

Results

Significant differences were found in the endpoints.

Results date posted

2020 Year 11 Month 26 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics

Healthy adults

Participant flow

50 participants completed and 50 subjects were incorporated into the analyses

Adverse events

Mild inflammation on the site where Libre sensor was attached to one subject was occurred.

Outcome measures

Blood glucose level and behavior change

Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2019 Year 12 Month 23 Day

Date of IRB

2020 Year 01 Month 15 Day

Anticipated trial start date

2020 Year 02 Month 06 Day

Last follow-up date

2020 Year 04 Month 01 Day

Date of closure to data entry


Date trial data considered complete


Date analysis concluded



Other

Other related information



Management information

Registered date

2020 Year 11 Month 26 Day

Last modified on

2021 Year 09 Month 01 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000048583


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name